Process Development and Technology Transfer Specialist

4 days ago


Brinny, Cork, Ireland Asset Recruitment Full time
Job Overview:

We are excited to offer a challenging opportunity for a Senior Technical Transfer Engineer to join our team. As a key member of our External Manufacturing (ExM) Technical Operation organization, you will be responsible for leading technical activities related to commercial manufacturing processes at our External Partners.

Key Responsibilities:
  • Collaborate with External Partners to drive business success and foster a shared culture that benefits our company, partners, and patients.
  • Manage technical activities, including the development of change control documents, process improvement projects, statistical analysis of process performance, and investigation of atypical events.
  • Oversee technical transfer activities, including authorship and/or review of required GMP documentation and regulatory filings.
  • Support Commercial and/or Technology Transfer Person-In-Plant Activities at External Partner sites.
  • E nsure that External Partners are prepared for all routine inspections and/or inspections related to new product introductions or transfers.
  • Partner with Operations, Quality, and Regulatory teams to develop standardized work to meet GMP requirements and current regulations.
  • Contribute to the creation, sharing, and adoption of business process and best practices strategies.
Essential Skills and Qualifications:
  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or other related science or engineering field.
  • 4+ years of post-bachelor's degree experience in a GMP functional area or support of a GMP functional area.
  • Strong communication skills in English and teamwork skills.
  • Approximately 25% travel requirement.


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